Compounding Guidance Creates Subtle Pressure On Traditional Compounders
FDA will enforce USP standards, a regulatory first.
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Iowa has contracted with a national pharmacy group to inspect facilities outside its borders. Although the program could serve as a potential model for a nationwide plan, it also could bring several problems.
State regulators seem to agree with FDA about confusion over regulatory responsibility, saying writing consistent definitions for compounding and manufacturing will help determine future FDA involvement.
Instead of asking why confirmatory trials take so long, the FDA commissioner suggests insurance companies ask what they can do to help answer those questions.